Research Studies

At Johns Hopkins: Do you or a family member suffer from depression? Researchers with J. Raymond DePaulo, Jr., M.D., seek volunteers for a Family Genetic Study. If you or a family member have been diagnosed with depression and have at least one brother or sister with depression or periods of low mood, your family may qualify to participate.

Participation involves having an interview with a psychiatrist and having a small blood sample taken. Reimbursement up to $75 is provided for completion of the diagnostic interview and blood sample. All information gathered will be confidential and results will be published in a manner to ensure anonymity.

Your family could assist our nationwide effort to find genes that contribute to major depression. Finding these genes could lead to better diagnoses and treatment for depression.

If you are interested in participating, or know of someone who might be, please contact the research staff, phone: 410-614-1017; e-mail: moods@jhu.edu. For more information, click here.

At Georgetown University: The psychopharmacologic research division in the Department of Psychiatry at Georgetown University is now enrolling volunteers for a new clinical trail. The trial is a double-blind, placebo controlled study using the FDA-approved antidepressants Effexor (venlafaxine) and Zoloft (sertraline) in patients with post-traumatic stress disorder (PTSD). The trial involves 15 weeks of treatment. Evaluation, office visits, and medication are at no cost to participants. The principal investigator is David M. Goldstein, M.D.

If you would like further information or if you would like to refer a patient to this study, please contact Barbara Wolff, R.N., at 202-687-8804 or Emma Thembani at 202-687-6355.

At Sheppard Pratt: Infectious Agents in Bipolar Disorder. The Stanley Research Program at Sheppard Pratt is looking for the possible role of infectious agents in bipolar disorder. Participation involves about two hours of your time and a blood sample. To participate you must be between the ages of 18 and 65 and have never used IV drugs. Upon completion of the study, you will be paid $20 cash. For more information, please call Faith Dickerson, Ph.D., at 410-938-4359.

Depression: Do You Feel It In Your Bones?

Women who have had depression may have low bone density, which can lead to osteoporosis. The University of Maryland School of Medicine and Baltimore VA Medical Center are seeking Research Volunteers for an investigational treatment study with a FDA-approved medication to determine its effectiveness in the prevention of osteoporosis in women with a history of depression.

If you are a woman:

40 years or older with

No regular menstrual cycles for at least 12 months and have a

Current or past clinical diagnosis of major depression

You may be eligible for this study. Please call the study coordinators for more details - (410) 605-7000 ext. 4781).

Volunteers will receive free medical evaluations, study drugs, and tests of bone density and will be reimbursed for travel expenses. Volunteers need not be veterans to be considered for participation.

AFFECTIVE DISORDERS AND PREGNANCY, Excerpts from a report on a presentation 1 by Sylvia Simpson, M.D., 2Smooth Sailing, Spring 1995, 2-4

...It's a common clinical dilemma: a woman taking medication for a mood disorder finds herself pregnant or decides to get pregnant. What should she do? Stay on her medication, or not? What are the risks that her mood symptoms will return if she stops taking it? What are the risks to the fetus if she stays on lithium or another of the growing variety of antidepressants, mood stabilizers, antipsychotics, or minor tranquilizers? ... Similarly, difficult questions arise when a woman who has just had a baby becomes depressed. At what point should she get psychiatric help? Should she consider medication? What are the risks to the newborn if she takes medication while nursing? These are just a few of the questions that Dr. Simpson addressed during her...presentation.

Although pregnancy traditionally has been regarded as a time of well-being, Dr. Simpson mentioned three studies documenting a variety of mood troubles during pregnancy. The incidence (occurrence) of depression was highest in the first trimester in two of the studies and in the third trimester in the third study....

Dr. Simpson discussed the three types of postpartum mood disturbances: postpartum blues (or "baby blues"), postpartum depression, postpartum psychosis.

Postpartum blues, which are characterized by mood lability (instability), sleep disturbance, and tearfulness, begin around day three after delivery and peak two days later. They are very common (40 to 70 percent incidence) and respond to support and reassurance.

Postpartum depression usually means a major depression with typical symptoms and without psychotic features. The woman also feels inadequate as a mother. These depressions usually begin within weeks of delivery and may last for weeks to months, even beyond the first year if not treated. Their incidence is thought to be 10 to 20 percent. About 20 percent of women who experience them have a history of depression; other risk factors are a family history of depression, lack of support, and negative life events. No association with age, parity (having had previous deliveries), social class, or obstetric difficulties has been noted. Unfortunately, few women with postpartum depression seek or receive treatment. With treatment (antidepressant medication, psychotherapy, and support), the prognosis is good.

Postpartum psychosis consists primarily of depression and mania with psychotic features. There are usually florid (pronounced) symptoms of mood lability, hallucinations, and delusions, as well as a sense of confusion and bewilderment. The psychosis usually begins within two weeks of delivery and requires hospitalization. (The highest-risk time for psychiatric admission in a woman's life is the first 30 days postpartum.) The incidence of postpartum psychosis is 1 to 2 per 1,000 births. Risk factors include a personal or family history of psychoses and having just delivered one's first baby. Initial treatment includes antipsychotic medications plus antidepressants (for unipolar depression) or lithium (for bipolar disorders). Some British clinicians suggest that if a week on medications brings no improvement, ECT (electroconvulsive therapy) should be used. Long-term treatment of postpartum psychosis includes antipsychotic medications for several months and then mood medications indefinitely if there have been recurrent episodes not related to pregnancy. The risk of recurrence is substantial; bipolar women have a 50 percent risk of recurrence with subsequent pregnancies, and unipolar women, a 30 percent risk.

(Patterns of affective disorder during pregnancy and postpartum period) Dr. Simpson presented information on pregnancy-related depression from the Johns Hopkins Bipolar Family study...Of the 230 women with an affective disorder who had ever been pregnant, 42 percent had experienced at least one pregnancy-related episode, and a third of those had experienced two or more. One-quarter of the episodes occurred during pregnancy and three-quarters during the postpartum period. ...Women with bipolar disorder (type I or II) tended to have more pregnancy-related depression than did women with recurrent unipolar disorder.

(Effect of medications during pregnancy) Dr. Simpson reviewed data about the teratogenicity (tendency to cause birth defects) of psychiatric medication. Critical periods in fetal organ development are:..gestational (pregnancy ) days..(day) 10...to...(day) 40. Among antidepressants, the tricyclics are thought to be fairly safe; the MAOI (monoamine oxidase inhibitor) phenelzine (Nardil) has been reported to cause birth defects when taken in the first trimester; and a controlled study of fluoxetine (Prozac) in pregnant women found an increased risk of miscarriage.

Fetal exposure to lithium in the first trimester is associated with congenital heart disease.... For women taking lithium, careful contraception is to be encouraged, and when a pregnancy is planned, the need to continue lithium should be weighed according to clinical factors. Women experiencing few affective episodes and long healthy periods can be gradually tapered off lithium before pregnancy. They can restart their medication in the second or third trimester, if necessary. Fetal exposure to carbamazepine (Tegretol) in the first trimester is associated with "minor" birth defects....

Fetal exposure to valproic acid (Depakote) in the first trimester has been reported to cause neural tube defects, particularly spina bifida, at a rate of 1 percent. Benzodiazepines (minor tranquilizers) are not contraindicated during pregnancy. Some of the neuroleptics (antipsychotics or major tranquilizers) have not been shown to cause birth defects and may be continued through pregnancy if needed in women with severe and chronic bipolar disorder.

Dr. Simpson also reviewed the effects of psychiatric medications on newborn and breast-feeding infants. Since all medications taken by the mother are excreted in breast milk, breast-feeding is almost always contraindicated for women on medication.

One mode of treatment which is greatly underutilized—and, with appropriate monitoring, thought to be relatively safe during pregnancy—is ECT. The usual indications for ECT treatment of depression apply during pregnancy, and mania not responding to medication can also be treated with ECT. It is an option that avoids exposing the fetus to possible teratogens in the first trimester.

Dr. Simpson closed with a discussion of the clinical management issues. Women on medication for an affective disorder who consult their doctor before getting pregnant should wait for a period of stable mood, avoiding predictable times of symptom exacerbation, before going off their medication and trying to conceive. They should also withdraw from their medications gradually to reduce the chance of relapse.

Women on medication for an affective disorder who consult their doctor after getting pregnant should be made aware of

the risk to the fetus and benefits to the mother of continuing the medication, and

the risks to both mother and fetus of discontinuing the medication (a mother's relapse may result in noncompliance with prenatal care, inadequate nutrition, suicide attempts, and possible injury to the fetus).

Ideally, women should be managed without medication in the first trimester, but if medications are needed, those with the lowest known risks should be used in the lowest effective doses. Dr. Simpson cautioned that these recommendations are based on the information we have today, and guidelines may need to be revised as more studies are reported.

_______________

1 Presented at a DRADA/Johns Hopkins symposium, Baltimore, MD, April 25, 1995.

2 Associate Professor of Psychiatry, Johns Hopkins University School of Medicine.

by Emile A. Bendit
Smooth Sailing: Spring 1995

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